FDA Warning Letters


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  1. Warning Letter: Failure to establish procedures (s7186c)

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    Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, the [redacted] used in the manufacturing of [redacted] products was changed from [redacted] to [redacted]. However, your validation records indicate [redacted] was used as the [redacted]. There are no records of design validation using [redacted] as the [redacted] furthermore, verification activities related to using [redacted] are not complete.

    View the original warning letter.


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  2. Warning Letter: Failure to provide documentation for validation (ucm181430)

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    Purchase software specific to contact lens firms, which has quality system modules. You stated that you had purchased the software and planned to have it installed by January 2009, with implementation and validation within 5 to 6 months. However, you did not provide any documentation regarding the software system, the validation plan, or your firm’s plan to train personnel on the use of the system.

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  3. Warning Letter: Failure to maintain quality system requirements (ucm152423)

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    Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 21 C.F.R. § 820.20(b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements. Additionally, you stated that your quality system has not kept pace with the growth of your firm’s business.

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  4. Warning Letter: Failure establish and maintain records (ucm166530)

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    Failure to evaluate and select suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 C.F.R. 820.50(a)(1). 17) Failure to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a)(3).

    View the original warning letter.


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  5. Warning Letter: Failure to validate computer system (s7045c)

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    Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR § 211.100(a)]. For example, your firm’s automated packaging line processes and their respective software systems have not been validated .

    View the original warning letter.


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  6. Warning Letter: Lack of validation testing (s6906c)

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    Your validation of your device design is incomplete in that the firm has not established a protocol for conducting validation testing and did not validate the software to ensure that devices conform to the defined user needs and intended uses, as required by 21 CFR §820.30(g). Specifically, you have made 1,900 revisions to the software in three years without conducting validation testing .

    View the original warning letter.


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  7. Warning Letter: Failure to maintain procedures, documentation (s6881c)

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    Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

    View the original warning letter.


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  8. Warning Letter: Lack of controls and audit trails (ucm1048180)

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    The [redacted] data acquisition system for the [redacted] UV/Visible spectrophotometers allows your analysts to modify, overwrite, and delete original raw data files. The spectrophotometers are used for dissolution testing of finished product, stability samples, and process and method validation studies. All laboratory personnel were given roles as [redacted] Managers, which allowed them to modify, delete, and overwrite results files. This system also does not include an audit trail or any history of revisions that would record any modification or deletion of raw data or files. Your laboratory computer system lacks necessary controls to ensure that data is protected from tampering, and it also lacks audit trail capabilities to detect data that could be potentially compromised.”

    View the original warning letter.


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  9. Warning Letter: Failure to Comply (s6876c)

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    • Failure to adequately validate manufacturing processes with a high degree of assurance, and approve and document the results of the validation activities, to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not validated the milling process and documented the validation results to ensure that the brass rounds are correctly milled to patients’ programmed [redacted] files [redacted] codes).
    • Failure to revalidate manufacturing processes in response to changes or process deviations, and document the results of the revalidation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(c). Specifically, your firm has not documented the results of the revalidation of the milling process after your firm repaired a loosened bushing on the tooling plate and [redacted] without established procedures in place for implementing these changes.
    • Failure to establish and maintain procedures for verifying or validating, approving, and documenting changes to a specification, method, process, or procedure, before implementation, as required by 21 C.F.R. § 820.70(b). Specifically, your firm has not established written procedures describing how changes to your milling process are to be verified or validated, approved, and documented.

     

    View the original warning letter.


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  10. Warning Letter: Failure to maintain validation documentation (s6847c)

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    “Specifically, your firm has not conducted quality audits and established adequate procedures for … acceptance activities and computer software validation … your firm has not established written procedures describing how it evaluates, verifies or validates, documents, and approves design changes. Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 C.F.R. § 820.70(i). FDA 483 Item 8. Specifically, your firm has not maintained documentation of the validation of the computer software used to (a) receive encrypted patient treatment data and decrypt/encrypt it; (b) convert decrypted patient treatment data into […] codes that are converted into […] codes that are then sent to your contract manufacturer’s […] milling machine to produce the compensators.”

    View the original warning letter.


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